A US District Court last week denied Santaris Pharma's second bid to have a patent-infringement lawsuit filed against it by Isis Pharmaceuticals thrown out, ruling that the company again failed to establish that its allegedly infringing activities were protected by a US statute that permits the use of patented inventions in drug development.
As a result, the litigation will continue, the court said.
The legal spat began in 2011 when Isis sued Santaris for infringing two of its US patents by providing antisense drug candidates and drug-discovery services to five pharmaceutical partners: Enzon, GlaxoSmithKline, Wyeth (now a part of Pfizer), Shire, and Pfizer.
The next year, Santaris asked the court to dismiss the case, arguing that its activities fall under the protection of 35 U.S.C. 271 (e)(1), a legal provision allowing companies to “make, use, offer to sell, or sell ... a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”
In a landmark 2005 US Supreme Court ruling, protection under the statute was extended to the use of patented inventions that are “reasonably related to the development and submission of any information” to the US Food and Drug Administration.
However, the court rejected Santaris' request as it was supported solely by a declaration by CSO Henrik Orum, who did not provide a “specific analysis of Santaris’s uses of the allegedly infringing compounds, methods, and processes.” At the time, the court also found that Santaris could have been selling patented technology to perform basic scientific research, not just to develop therapeutic candidates.
Late last year, Santaris made another attempt to end Isis' legal attack using 35 U.S.C. 271 (e)(1), claiming that each of the collaborations at the heart of the litigation contemplated that the pharmaceutical partner would "select specific RNA targets that were each related to a human disease," and that for each target, Santaris would design in its native Denmark a library of antisense compounds directed to it.
Santaris would conduct in vitro experiments on those compounds and, after further work by the pharmaceutical firms, drugs based on lead compounds would be the subject of investigational new drug application submissions to the FDA, it stated. These "would enable human clinical trials, followed by the submission of a [new drug application], further review by FDA, and eventual marketing approval."
The court was not swayed by Santaris, however, last week calling into question whether its allegedly infringing activities were "reasonably related" to FDA submissions.
"At the time Santaris entered into [the deals with Pfizer and others] … its US collaborators had identified few, if any, of the targets Santaris would be attempting to modify using antisense technology," the court stated. "Moreover, because Santaris was to develop a library of antisense compounds for each selected target, the specific compounds Santaris would be using to modify each of the selected targets were also unknown."
Although Santaris may have had a "reasonable basis" for believing that one or more antisense molecules could affect targets selected by its US collaborators, it presented no evidence that, at the time it entered into the agreements, that it met the requirement of knowing the "particular biological process and particular physiological effect that using Isis’s patented inventions would have in relation to how each antisense compound in its libraries would affect each target," the court added in its latest ruling.
On the contrary, the company would have to wait for its partners to select a target, develop a library of antisense oligos for each of them, then screen all the compounds for their effects on a given target using, among other things, Isis' patented inventions, the court stated. "Then, after even more work by the US pharmaceutical companies, information from Santaris’s research results might be submitted to the FDA."
In light of these findings, the court denied Santaris's motion to dismiss the case. In a filing from this week, Isis asked that the court to issue a new order setting dates and deadlines for the case after ruling that it will move forward.